510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K113435Substantially Equivalent

Ace Carbon Dioxide(co2-Lc) Reagent, Ace Direct Bilirubin Reagent, Ace Total Bilirubin Reagent, Ace Magnesium Reagent

Alfa Wassermann, West Caldwell NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113435 is the FDA 510(k) clearance record for ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT, a class II device, cleared for Alfa Wassermann on under FDA product code KHS (Enzymatic, Carbon-Dioxide). FDA records list 9 510(k) clearances for Alfa Wassermann, from to . As of , FDA records show no recalls naming K113435.

Clearance record

Decision date
Received
(224 days to decision)
Product code
KHS Enzymatic, Carbon-Dioxide
Regulation
21 CFR 862.1160
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Alfa Wassermann 4 Henderson Dr., West Caldwell NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KHS

Trailing 12 months

FDA records hold no clearances under product code KHS in the trailing twelve months.

FDA records show no clearances under product code KHS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KHS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260